K233595
- 510(k) number
- K233595
- Device name
- Genesys Spine Sacroiliac Joint Fusion System with Navigation
- Applicant
- Genesys Spine TX · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-03-29
- Date received
- 2023-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K233595.pdf
Official FDA record: K233595
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.